Catalog Number

8044

Brand Name

Curity

Version/Model Number

8044

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In GS1

MRI safety Status

Labeling does not contain MRI Safety Information

Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437)

-

Device labeled as "Not made with natural rubber latex"

-

For Single-Use

Yes

Prescription Use (Rx)

-

Over the Counter (OTC)

Yes

Kit

-

Combination Product

-

Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)

-

FDA Premarket Submission

-

Product Code

FRL

Product Code Name

FIBER, MEDICAL, ABSORBENT

Public Device Record Key

7cbc2bcd-fe62-46d8-a36e-1322003b5583

Public Version Date

August 24, 2021

Public Version Number

3

DI Record Publish Date

June 27, 2018

Package DI Number

10884521060388

Quantity per Package

1200

Contains DI Package

00884521060381

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

CASE